Wound treatment device employing negative pressure

ABSTRACT

Devices and methods for wound treatment are disclosed. A chamber may define a treatment space having an interior engineered surface including a plurality of structures configured to provide pathways for the distribution of negative pressure and to exert mechanical stress on a wound. In some specific embodiments, the devices and methods may treat wounds on the head, neck, and face. One or more tubes may be in fluid communication with the treatment space to facilitate the application of negative pressure, the introduction of therapeutic agents, and the removal of wound material.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/729,230 titled “Wound Treatment Device Employing Negative Pressure”filed on Dec. 27, 2019, which is a continuation of U.S. patentapplication Ser. No. 15/638,629 titled “Wound Treatment Device EmployingNegative Pressure” filed on Jun. 30, 2017, which is a continuation ofU.S. patent application Ser. No. 14/530,107 titled “Wound TreatmentDevice Employing Negative Pressure” filed on Oct. 31, 2014, which is acontinuation-in-part of U.S. patent application Ser. No. 14/092,004titled “Wound Treatment Device Employing Negative Pressure” filed onNov. 27, 2013, which in turn is a continuation of U.S. patentapplication Ser. No. 12/601,394, now U.S. Pat. No. 8,632,523, titled“Wound Treatment Device Employing Negative Pressure” filed on Nov. 23,2009, which is a U.S. national stage application under 35 U.S.C. § 371of International Patent Application Serial No. PCT/US2008/064897 filedMay 27, 2008, which claims the benefit of priority to U.S. ProvisionalPatent Application Ser. No. 60/931,599 titled “Wound Treatment DeviceEmploying Negative Pressure” filed May 24, 2007, the entire disclosureof each of which is hereby incorporated herein by reference in itsentirety for all purposes.

FIELD OF THE TECHNOLOGY

The disclosure relates generally to wound treatment and, moreparticularly, to devices for treating wounds with negative pressureand/or therapeutic agents.

BACKGROUND

Many wounds can be treated by the application of negative pressure. Themethod of such treatment has been practiced for many years. The benefitsof such treatment can include: reduction of edema; reduction of woundexudate; reduction of wound size; and stimulation of formation ofgranulation tissue. Existing devices and appliances for the provision ofnegative pressure wound therapy are complex. Such devices typicallyencompass a porous insert such as foam or gauze that is placed into thewound; a tube connecting the inner space to a source of suction; aflexible cover draped over these components and sealed to the skinaround the wound; an electrically powered suction pump; controls tooperate the pump and monitor the system; containers to collect woundfluids; filters to process the materials removed from the wound; andsafety systems to prevent harm to the patient and to block the escape ofbiological materials into the outside environment. These devices areexpensive, labor intensive, and restrictive of patient mobility. Thesedevices are generally not considered suitable for wounds on certainareas of the body, including wounds on the face, neck, and head. Themany components, particularly the seals around the insert and the tube,tend to leak. Therefore, suction must be applied either continuously orfrequently.

Continuous suction is typically achieved by a vacuum pump powered by anelectric motor. Such systems require complex means to measure, monitor,and control the operation of the pump to ensure the safety of thepatient. In addition, many negative pressure devices are contraindicatedin the presence of necrotic tissue, invasive infection, active bleeding,and exposed blood vessels. They require the use of a porous insert(sponge, foam, gauze, mesh, etc.) in the wound. The insert may presenttwo problems: growth of tissue into the insert, and the harboring ofinfectious and/or undesirable materials in the insert. Wound tissue cangrow into and around such inserts, thereby causing adverse results tothe healing process. Moreover, such inserts can retain wound fluid andmicroorganisms, and therefore can become contaminated and/or infected,presenting an adverse effect to the healing process. In addition, thehigh cost of these devices may deter or delay their use on patients.

Existing negative pressure treatment devices are labor intensive sincethey require the user to assemble, fit, and customize a number ofcomponents. First, the user must prepare, trim, and size an insert offoam, gauze, mesh, or other material that will be placed in the wound.Next, the user must position a tube in the insert, and then cover thetube and insert with a material that is intended to create a leakproofseal. In practice, and as mentioned above, such compositions tend toleak, requiring the frequent application of suction in order toestablish and re-establish negative pressure within the space about thewound. In addition, currently available negative pressure devices andsystems block the view of the wound, making monitoring and diagnosismore difficult. This is particularly problematic for wounds on the head,neck and face, such that existing negative pressure devices are notsuitable for such wound treatment. Therefore, an improved device forapplying negative pressure to wounds is needed.

SUMMARY

In accordance with one or more embodiments, devices and methods fortreating wounds with negative pressure and/or therapeutic agents aredisclosed.

In some embodiments, a device for wound treatment may have a chamberthat includes an inner surface and a sealing portion that defines anisolated treatment space, a plurality of embossed structures arranged ina pattern on the inner surface of the chamber, the structures having aheight of about 0.2 mm to about 5 mm and spaced about 0.2 mm to about 10mm from one another, the structures configured to directly contact awound and to create pathways for distributing negative pressure betweenthe inner surface of the chamber and the wound, and at least one tubehaving a first end connected to the chamber, the at least one tube beingin fluid communication with the isolated treatment space so as to enableat least one selected from the group of applying negative pressure tothe isolated treatment space and applying a therapeutic agent to thewound.

In other embodiments, a wound treatment device may include a chamberconfigured to enclose a head and neck region of a patient, the chamberbeing made of an impermeable material that is sufficiently thin toconform to the head and neck of the patient, the chamber having asealing portion at a base and an interior surface defining an isolatedtreatment space, a plurality of embossed structures on the interiorsurface of the chamber, the structures being configured to directlycontact a wound and to create pathways for distributing negativepressure between the inner surface of the chamber and the wound, and atleast one tube connected to the chamber and in fluid communication withthe isolated treatment space so as to enable at least one selected fromthe group of applying negative pressure to the treatment space andapplying a therapeutic agent to the wound.

In at least some embodiments, a method of treating a patient having afacial wound may involve debriding the facial wound, fitting a woundtreatment device as described herein over a head of the patient,applying at least one therapeutic agent to the wound via the device at aconcentration of up to or greater than about 1000 times a concentrationsuitable for intravenous delivery, and applying negative pressure woundtherapy to the treatment space of the device for a sufficient durationto effect healing of the wound.

In one aspect, the present disclosure is summarized as a device forwound treatment, comprising a chamber that includes an inner surface anddefines a treatment space, the chamber being made of a flexible,impermeable material. The device further includes a plurality ofstructures configured to exert mechanical stress on a wound andconfigured to create pathways through which negative pressure can bedistributed and maintained in the treatment space, the plurality ofstructures intruding from the inner surface of the chamber into thetreatment space. The device further includes a tube having a first endconnected to the chamber, the tube being in fluid communication with thetreatment space so as to enable at least one selected from the group ofapplying negative pressure to the treatment space and applying atherapeutic agent.

In some embodiments, the plurality of structures and the chamber arepart of a single ply of material. In addition, in some embodiments, eachof the structures in the plurality of structures is semi-rigid.

In some embodiments, the device includes a wedge-shaped manual pump, andthe treatment space is in fluid communication with the wedge-shapedmanual pump. The wedge-shaped manual pump may include a spring thatbiases the wedge-shaped manual pump to an uncompressed position.

The foregoing and other objects and advantages of the disclosure willappear in the detailed description that follows. In the description,reference is made to the accompanying drawings that illustrate anon-limiting preferred embodiment of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like reference characters generally refer to the sameparts throughout the different views. Also, the drawings are notnecessarily to scale, emphasis instead generally being placed uponillustrating the principles of the invention and are not intended as adefinition of the limits of the invention. For purposes of clarity, notevery component may be labeled in every drawing. In the followingdescription, various embodiments of the present invention are describedwith reference to the following drawings, in which:

FIG. 1 is a perspective view of a wound chamber treatment device with atube leading from a chamber to a suction source;

FIG. 2 is a side sectional view of the device in FIG. 1;

FIG. 3 is a sectional view of the device in FIG. 1 with an additionaltube leading to a port;

FIG. 4 is a sectional view of the device in FIG. 1 with a branching tubeleading to a port;

FIG. 5 is a perspective view of the end of the tube communicating withthe interior chamber space;

FIG. 6 is a side sectional view of structures engineered on and into theinterior surface of the chamber wall, where the structures are ofuniform size and shape, and are spaced uniformly apart;

FIGS. 6A-6C present schematics of patterned engineered structures inaccordance with one or more embodiments;

FIG. 7 is a side sectional view of two groups of structures engineeredon and into the interior surface of the chamber wall, where one groupintrudes into the chamber space, the other group intrudes to a lesserextent, and structures from these groups alternate in a regular pattern;

FIG. 8 is a side sectional view of three groups of structures engineeredon and into the interior surface of the chamber wall, where such groupshave varying degrees of intrusion into the chamber space and alternatein a regular pattern;

FIG. 9a is an overview of structures engineered on and into the interiorsurface of the chamber wall, where the structures consist of raisedridges;

FIG. 9b is a side sectional view of the raised ridges of FIG. 9a withrounded edges;

FIG. 9c is a side sectional view of the raised ridges of FIG. 9a withsquare cross sections;

FIG. 10 is an overview of the raised ridge structures shown in FIG. 9 a,with the addition of raised dome structures positioned among the ridges

FIG. 11 is an overview of raised ridge structures engineered on and intothe interior surface of the chamber wall, where two parallel lines ofsuch structures form a channel;

FIG. 12 is an overview of raised dome structures engineered on and intothe interior surface of the chamber wall, where two parallel lines ofsuch structures form a channel;

FIG. 13 is a view of a wound chamber, showing a pattern of channelsleading to the center of the chamber and then to the tube communicatingfrom the interior of the chamber space;

FIG. 14 is a view of a radiating pattern of channels leading to thecommunicating tube;

FIG. 15 is a view of a branching pattern of channels leading to thecommunicating tube;

FIG. 16 is a view of a sub-branching pattern of channels leading to thecommunicating tube;

FIG. 17 is a side sectional view of a fold in the chamber wall;

FIG. 18a is a side sectional view of a fold in the chamber wall, withstructures engineered on and into the inner surface of the fold, whichstructures maintain continuous open space within the fold;

FIG. 18b is a side sectional view of the fold in the chamber wall ofFIG. 17 with structures engineered on the inner surface of the fold;

FIG. 19 is a view of a wound chamber configured as a tube for placementover a limb, and having engineered structures and channels on theinterior surface of the chamber wall;

FIG. 20 is a sectional view of the device in FIG. 1 showing a fluidcollector placed before the suction source;

FIG. 21 is a sectional view of a suction device in the form of a squeezebulb of deformable material;

FIG. 22 is a sectional view of a suction device in the form of aflexible chamber containing one or more compression springs;

FIG. 23 is a sectional view of a suction device in the form of awedge-shaped chamber containing one or more torsional springs;

FIG. 24 is a sectional view of the device in FIG. 23 containing a flatspring;

FIG. 25 is a sectional view of a suction device with a trap and filterincorporated into the exhaust port;

FIG. 26 is a perspective view of a wound chamber treatment device forwounds on the face, head, and neck in accordance with one or moreembodiments;

FIG. 27 is a perspective view of another embodiment of a wound chambertreatment device for wounds on the face, head, and neck in accordancewith one or more embodiments;

FIG. 28 is a perspective view of an unassembled wound chamber treatmentdevice for wounds on the face, head, and neck in accordance with one ormore embodiments; and

FIG. 29 is a front view of an assembled wound chamber treatment devicefor wounds on the face, head, and neck in accordance with one or moreembodiments.

While the invention is susceptible to various modifications andalternative forms, specific embodiments thereof have been shown by wayof example in the drawings and are described below in detail. It shouldbe understood, however, that the description of specific embodiments isnot intended to limit the invention to the particular forms disclosed,but on the contrary, the intention is to cover all modifications,equivalents, and alternatives falling within the spirit and scope of theinvention as defined by the appended claims.

DETAILED DESCRIPTION

The present disclosure is directed to providing a simple, safe,disposable, and cost-effective device that is easy to install andoperate, that allows freedom of motion to the patient, and thatovercomes, or at least reduces the effects of, one or more of theproblems set forth above. In at least some embodiments, the presentdisclosure does not require the use of an interface layer such as aporous insert. In some embodiments, a one-piece, two-piece, ormulti-piece construction of the device is suitable for patient treatmentand eliminates virtually all leaks, therefore preserving and maintainingnegative pressure within the wound without the need for constant orfrequent regeneration of negative pressure. In addition, the structureof the device is configured to promote wound healing and to createpathways through which negative pressure can be distributed andmaintained in the treatment space. The device may contact the wounddirectly, without the use of an interface layer such as a porous insert.The indications for the present disclosure may be expanded beyond thelimitations imposed on current devices. The cost-effectiveness of thepresent disclosure may lead to the provision of negative pressure woundtherapy on a more widespread basis and earlier in the timeline of woundcare.

In accordance with various aspects and embodiments, the devices andmethods of the present disclosure may be used to treat full and partialthickness burns, traumatic wounds, post surgical wounds, infectedwounds, post infection wounds, skin loss due to dermatologicalconditions, and other conditions that result in skin and deep tissueloss. The devices and methods may be used anywhere on the human body,and may also be suitable for veterinary applications. The devices andmethods may, for example, be used for wound preparation to preventscarring as well as the fixation and protection of skin grafts duringwound treatment. In some specific non-limiting embodiments discussedherein, wound treatment may relate to injuries occurring on the head,face, and/or neck. For example, a patient's cheeks, forehead, and/orcrown may be treated. The head including facial tissue presents uniquechallenges which may be addressed in accordance with one or moreembodiments.

One aspect of the present disclosure is seen in a wound treatment deviceincluding a chamber defining a treatment space around the wound. Theflexible adhesive base of the chamber forms a water-tight and gas-tightseal. A tube communicates from the treatment space to a source ofsuction. In at least some embodiments described herein, the source ofsuction is capable of generating and/or maintaining sub-atmosphericpressure within an enclosed space. The suction source also serves as areceptacle for materials removed from the chamber, including woundfluid. All components preferably are inexpensive, lightweight, anddisposable.

Referring to FIGS. 1 and 2, views of a wound treatment device 20 areprovided. The device 20 includes a chamber 22 defining a treatment space24 and a base 26 that may be sealed to a skin surface 28 of a patientover a wound 30. In the illustrated embodiment, the chamber 22 has abellows configuration with a fold 23. However, the invention is not solimited, and other configurations of a chamber formed of a flexible,moisture and gas impermeable material may be used. The chamber may alsobe transparent to allow for visual inspection of the wound duringtreatment. In accordance with certain embodiments, the material issubstantially transparent. In other embodiments, the material may besubstantially opaque. The use of an impermeable material is particularlyadvantageous for introducing therapeutic agents to the wound.Additionally, the impermeable nature of the chamber material preventswater loss from the wound, which facilitates improved healing. Materialsfrom which the device 20 may be made will be discussed in further detailbelow. The device 20 can be designed for use with any wound on any bodypart, including both human and veterinary applications. Variousgeometries such as circular, square, rectangular, tubular, pouch,envelope or other shapes may be implemented based on the intendedapplication. In accordance with some embodiments, chamber 22 definingtreatment space 24 may be configured for a specific body part. Forexample, a chamber in the form of a tube or sleeve for placement over alimb is shown in FIG. 19, whereas a chamber in the form of a hood forplacement over a head is shown in FIG. 26 as described further below.

Still referring to FIGS. 1 and 2, a dermal or cutaneous adhesivematerial may be provided on a bottom surface of the base 26 forproviding a fluid-tight seal with sufficient adhesive strength toprevent inadvertent removal of the chamber 22 or breach of thefluid-tight seal during normal patient movement. Numerous adhesivematerials sufficient for these purposes are known to those of ordinaryskill in the art.

In accordance with some embodiments, device 20 can be specificallydesigned for treating wounds occurring on the head, face, and/or neck.The device may cover only the head, or both the head and neck. Referringagain to FIG. 26, a chamber may be formed that fits over the head andattaches at the base of the neck for example at, or proximate, thecollar bone. In some embodiments, the chamber may be defined by a singlepiece of material, or a two or more piece design may be implemented. Thedevice may be oversized to fit any size head or may be customized.Oversized devices may lead to the presence of wrinkles in use which maybe advantageous for negative pressure distribution. In accordance withother embodiments and referring to FIG. 26, the device may be comprisedof two pieces 201A and 201B that may adhesively join to form a seam 202,for example, around the midline of the head and across the ears. In someembodiments, the pieces may be joined by other methods, and may forexample, by a zipper type or ziploc seal. Still, in accordance withother embodiments and as shown in FIG. 27, the device may be made from aplurality of pieces that contour the face.

The head device may or may not have openings for the nose and mouth. Ifthe device is constructed to cover the nose and mouth, the nose andmouth may be surgically sealed for treatment. For example, softconforming obturators, or alternatively, sutures may be used. Referringto FIG. 28, a patient being treated with a device 20 covering the noseand mouth may breathe via an installed tracheostomy tube 203 and be fedvia an installed gastrostomy tube 204. These tubes may be fitted outsideof the device, for example, at the neck. Contact lenses (not shown),such as oversized lenses, may be used to protect the eyeballs duringtreatment.

A tube 32 is attached to the chamber 22 preferably at a location spacedabove the base 26 and communicates with the treatment space 24. The tube32 is constructed to maintain its shape without collapsing and to permitthe passage of wound fluids and wound debris. The tube 32 may bepermanently fixed to the chamber 22, or a fitting, such as a tubularport 25 may be provided to allow the attachment and removal of the tube32 or any other device that can deliver material or therapies to, orremove material from, the treatment space 24. The tube 32 may terminateat a wall of the chamber 22, or it may extend through the wall adistance and terminate within the treatment space 24, where it maycommunicate with such space, with channels formed on the inner surfaceof the chamber wall, or with folds formed in the chamber wall. The tube32 is sealed to the chamber 22 in such a manner as to prevent the escapeof liquid or gas from the treatment space 24 to the outside environment.A distal end of the tube 32 terminates at a device that generatessub-atmospheric pressure, such as suction device 34. The suction device34 may be a pump, although other types of devices may be used asdiscussed below. A fitting 33 may be provided to permit the detachmentand reattachment of a suction device 34 to the tube 32.

Referring to FIG. 28, when device 20 is used to treat face, head, aand/or neck wounds, the device 20 may comprise a plurality of tubularports 25 for communication with one or more tubes 32. The ports 25 maybe strategically placed based on the geometry of the chamber. At leastone tubular port 25 may be located at the top of the device and at leastone tubular port 25 may be located at the bottom of the device. Inaccordance with some embodiments, tubular ports 25 may be positioned onthe side of the patient's face, at the temples proximate the ears. Insome embodiments, there are at least two tubular ports present.

Turning to FIG. 3, a sectional view of the device 20 is provided,showing a second tube 35 attached to the chamber 22 and communicatingwith the treatment space 24, with channels, or with folds. A distal endof the tube 35 terminates in a portal 36. The disclosure is not limitedto any number of communicating tubes, and multiple tubes and portals maybe provided for accessing the treatment space 24. FIG. 4 shows thedevice in FIG. 1 with a branch of the tube 32 that leads to a portal 36.The portal 36 may be used for the delivery of therapeutic agents—such asantimicrobials, antibiotics, antifungals, and analgesics—prior to,during, or after the delivery of negative pressure. As such, the portal36 may be a lure configured for attaching to a container or a syringe.Alternatively, therapeutic agents may be delivered through the same tube32 that communicates with the suction device 34.

In accordance with some embodiments, the device may allow for thedelivery of a therapeutic agent directly to the wound. As such, thetherapeutic agents can be delivered in concentrations significantlyhigher than could otherwise be administered intravenously or orally. Forexample, antibiotics can be applied directly to the wound atconcentrations in a range from about the conventional oral concentrationto up to about 1000 times the conventional oral concentration, or evenhigher. If ingested or administered directly to the bloodstream, theseconcentrations would be toxic to the body. Topical applicationfacilitates the use of significantly higher concentrations thatfacilitate healing. Combinations of therapeutic agents, such asanalgesics, antibiotics, and chemical debriding agents may also be used,and may advantageously reduce or eliminate the need for surgicaldebridement of the wound.

Turning now to FIG. 5, the end of the tube 32 extending into the chamberspace 24 is shown with multiple holes 44. The purpose of the holes 44 isto ensure that gases, liquids, wound fluid, debris, and other materialscan flow and move out of the chamber space 24 into the tube 32 withoutimpediment.

The wound may advantageously be monitored through the substantiallytransparent chamber material. The negative pressure device 20 may alsobe equipped with sensors to monitor certain parameters within thechamber space 24. For example, oxygen, carbon dioxide, pH, temperature,and other parameters may be measured and monitored.

Referring to FIG. 6, the interior surfaces of the chamber wall may beconfigured with structures 40 that are engineered on the surfaces. FIGS.6A-6C present schematics of different patterned engineered structures inaccordance with one or more non-limiting embodiments. The portions ofthe interior surfaces with engineered structures 40 may be varied fromthat shown in the figures, and preferably a high percentage of theinterior surfaces include engineered structures 40. The structurespreferably cover at least 50% of the interior surfaces, and morepreferably at least about 95% of the interior surfaces. These structuresare raised when viewed from within the chamber space 24, and theyintrude into such space in directions generally perpendicular to theinterior surfaces of the chamber space 24. These structures can be anyshape, including without limitation a cone, a pyramid, a pentagon, ahexagon, a half sphere, a dome, a rod, an elongated ridge with roundedsides, or an elongated ridge with square sides. The structures can beprovided as identical shapes, or in any combination of shapes. Thestructures can be provided with identical sizes, or in any combinationof different sizes. The structures can be provided in a regular orirregular pattern on the surface. The distance of intrusion into thechamber treatment space 24 from the chamber wall by such structures(height of such structures) is preferably between 0.01 mm and 20 mm,preferably between 1 mm and 1 cm, and most preferably about 2 mm. Thespacing between such structures is preferably between 0.01 mm and 5 cm,and the spacing for example, is most preferably about 2 mm apart. Insome embodiments, about 2 mm high structures are arranged about 2 mmapart. When larger structures are used, the structures may be spacedfurther apart and when smaller structures are used, the structures maybe spaced closer together. For example, a configuration of pyramids of0.2 mm in height may be spaced about 0.2 mm apart, whereas aconfiguration of larger pyramids of about 5 mm high may be spaced 10 mmapart.

The engineered structures 40 interface with the wound surface during useof the device 20. The engineered structures may directly contact thewound surface. One purpose of these structures is to ensure thatnegative pressure established within the chamber space 24 is evenlydistributed and maintained throughout such space. As negative pressureis established within the tube that leads to the source of suction orsub-atmospheric pressure, the chamber will lie tighter against the woundtissue. The device 20 includes the engineered structures 40 in order todefine pathways to establish, distribute, and maintain negative pressureacross the wound surface and prevent complete contact between the innersurfaces of the chamber and the wound tissue. Without such structures,the chamber wall would make complete contact with the wound surface. Asa result, there would be no space within which negative pressure couldbe established, distributed, and maintained. Therefore, the engineeredstructures are preferably semi-rigid. The term “semi-rigid” should beunderstood as meaning that deformation only occurs at a microscopiclevel under operating negative pressures in the range of 0.5-2 psi.Alternatively, the engineered structures may be somewhat flexibledepending on the spacing between the structures. In addition, thestructures are engineered to reduce the extent to which wound tissue canenter the space between the structures, so that a sufficient amount ofopen space is maintained. The engineered structures may be strategicallypatterned on the surface to produce desired negative pressure pathwayswithin the chamber.

An additional purpose of these structures is to serve as a form ofstimulation to the wound to produce beneficial results, includingwithout limitation the formation of granulation tissue and an increaseof micromechanical forces. Such mechanical forces provide stimulation toa portion of the wound tissue, which has been suggested as acontributing factor to the effectiveness of negative pressure woundtherapy. From the above discussion and the figures, it should beunderstood that the flexible chamber is movable over a range ofpositions. The range of positions includes a first position, such as theposition shown in FIGS. 1 and 2, in which the engineered structures 40are spaced apart from the opening of the chamber defined by the base 26.The range of positions also includes a second position in which at leastsome of the engineered structures 40 are positioned in the opening ofthe chamber. The second position is preferably a position in which theengineered structures 40 engage the wound.

The chamber wall can be formed of any appropriate medical grade materialthat has the following characteristics: flexibility, conformability, gasimpermeability, liquid impermeability, the ability to be formed, tooled,and engineered, and the ability to retain the shape, function, andeffectiveness of raised structures under desired ranges of negativepressure. The material should generally deter adhesion and in-growth.The material is preferably transparent to allow visual inspection of thewound during treatment. In addition, the material is preferablyhypo-allergenic and provided to a medical facility in a sterilecondition. For example, the chamber device may be made of a flexible,conformable material such as polyurethane, polyethylene, or silicone,although other similar materials may also be used. The material may havea thickness in the range of about 5 mm to about 100 mm. In someembodiments, the material may have a thickness of from about 1 mm up toabout 100 mm. In some specific embodiments, a 5 mm polyurethane membranemay be used to form the treatment chamber.

The chamber is preferably designed to provide sufficient material to lieagainst the surface of the wound tissue without special sizing,trimming, or other customizing operations. The chamber may be made froma single ply of material, or may be constructed of multiple layers ofmaterial in and on which the structures are engineered. It should beunderstood that a single ply chamber may be made of multiple sheets ofmaterial during manufacturing, but is provided to a medical facility ina state in which the multiple sheets are bonded or otherwise connectedto one another. For example, individual three dimensional shapes may beadhered or bonded to the inner surface of the chamber wall duringmanufacturing to provide the engineered structures. A single ply chambercould also be formed from a single sheet of material that defines boththe chamber walls and the engineered structures. For example, theengineered structures may be embossed. Alternatively, a multiple layerchamber is provided to a medical facility in a state in which layers ofmaterial are stacked to form the chamber. For example, the layer facingthe interior treatment space of the chamber could be a layer containingengineered structures that is bonded onto a generally flat layer ofmaterial (or multiple sheets of generally flat layers) by a medicalpractitioner.

The engineered structures can be made by techniques familiar to those inthe art, such as embossing, stamping, molding, forming, or bonding. Ifthe structures are created by embossing their shape into the material,the embossed structures may be left in a concave state relative to theoutside of the chamber as shown in FIG. 6. Embossed structures may alsobe formed on a single ply of material that also forms the walls of thechamber and the base. This may provide a chamber that is relativelyflexible with semi-rigid structures on a single ply of material.Alternatively, the cavities may be filled with a suitable material torender the structures solid. As another alternative, solid structurescan be affixed to the inner surfaces of the chamber. The raisedstructures on the inner surfaces of the chamber wall can be configuredand distributed in a number of patterns. For example, FIG, 6 is a sidesectional view of a portion of a chamber wall, showing engineeredstructures 40 on the interior surface of the material that facestreatment space 24. Structures 40 are identical in shape and size, andare positioned uniformly apart from one another. As another example,FIG. 7 is a side sectional view showing engineered structures 41 and 42intruding into the chamber space, where structures 41 intrude fartherthan structures 42, and the structures are configured in a regularalternating pattern of 41-42-41-42 and so forth. As yet another example,FIG. 8 is a side sectional view showing engineered structures 43, 44,and 45 intruding into the chamber space, where structures 43 intrudefarther than structures 44 and 45, structures 44 intrude less thanstructures 43 but farther than structures 45, and structures 45 intrudeless than structures 43 and 44. These structures are configured in aregular alternating pattern of 43-45-44-45-43-45-44-45-43 and so forth.The embodiment shown in FIG. 8 makes it difficult for soft wound tissueto penetrate all of the spaces among the raised structures. A sufficientamount of continuous space is established to make possible thedistribution of negative pressure, as well as the addition of fluids andtherapies and the removal of fluids and materials from the wound. As yetanother example, FIG. 9a is an overview of a portion of the chamberwall, showing engineered structures 47 in the form of raised ridges. Theengineered structures 47 may be rounded (FIG. 9b ), square (FIG. 9c ),or a combination thereof when viewed from the side. As yet anotherexample, FIG. 10 is an overview showing engineered dome structures 48interspersed with ridge structures 47. The engineered dome structures 48are preferably semi-spherical when viewed from the side, although othershapes are contemplated.

The distribution and maintenance of negative pressure within the chamberdevice and at all points on the wound may be enhanced by providingdefined channel spaces as pathways among the raised engineeredstructures for the distribution of negative pressure. However, definedchannel spaces are not required for providing fluid pathways within thetreatment space. FIG. 11 is an overview of a portion of the chamberwall, showing structures 47 arranged in two parallel lines to formchannel 49. FIG. 12 shows a channel 49 formed by two parallel lines ofraised domed structures 48. Such channels can be configured in variouspatterns, such as radial, circular, concentric, or branching. FIGS.13-16 show overviews of patterns of channels 49 leading from tube 32along the interior surface of chamber 22 facing treatment space 24. Foreach pattern, the channel 49 defines a space that opens directly to thetreatment space 24. The space preferably opens to the treatment space 24over the entire length of the channel 49. The distribution andmaintenance of negative pressure within the chamber device and at allpoints on the wound can also be enhanced by the use of folds in thechamber wall to create additional channel space for the distribution ofnegative pressure. When negative pressure is established within thechamber, the material will tend to fold along the pre-formed location.FIG. 17 shows a channel 50 formed in a fold of the chamber wall. Thechannel 50 defines a space that opens directly to the treatment space24. The space preferably opens to the treatment space 24 over the entirelength of the channel 50. In order to increase the amount of channelspace within such fold, the walls of the fold can be configured withstructures that prevent the collapse of such space, and ensurecontinuous open space for the distribution and maintenance of negativepressure, and the passage of liquid, gas, and other material. As analternative, FIG. 18a shows engineered structures 52 that prevent thetotal collapse of the fold, and ensure continuous channel space 51. Allchannel spaces created on the interior surface of the chamber wall or bymeans of folds function as means to increase the effectiveness ofdistributing and maintaining negative pressure within the chamber, andalso as means to enhance the effectiveness of removing gas, liquid,wound fluid, debris, and other materials from the chamber treatmentspace. As another alternative, FIG. 18b shows an embodiment similar tothe embodiment shown in FIG. 17 with the addition of engineered raisedstructures 52 on opposite sides of the fold. The engineered structures52 are provided so that the fold will not collapse to the point whereall of its interior surfaces form a tight seal against the movement ofnegative pressure. However, some of the interior surfaces, such as thoseadjacent to the fold, preferably contact the wound to providestimulation as discussed above. The folds described in the previousembodiments are preferably formed at certain defined areas by molding orembossing the surfaces of the chamber 22.

FIG. 19 shows a wound chamber device 120 for delivering negativepressure and therapeutic substances in the form of a tube that can beplaced over a limb. The wound chamber device 120 is generallycylindrical and includes an open end and a closed end, though thechamber may have other shapes to accommodate other body parts, and mayfor example, be suitable for fitting over the head. The open end ispreferably sealed with a cuff or collar (not shown), and the open endmay include adhesive on the interior surface. The wound chamber device120 includes engineered structures 40 and channels 49 on the interiorsurface of the chamber wall.

As shown in FIG. 20, a fluid collector 60 may be positioned on the tube32 between the chamber 22 and the suction device 34. The collector 60 isintended to receive fluid extracted from the chamber space 24 and debrisor material from the wound and store such materials for eventualdisposal. The collector 60 may be detachable from the tube 32, in orderto replace a full collector with an empty collector.

Suction for the wound treatment device is provided by a suction device34, which may be a pump that is connected and disconnected to thechamber device by appropriate connectors to provide sub-atmosphericpressure. Although the wound chamber can be used with a motor drivenpump, it is also effective with a hand-powered device actuated by thecaregiver or patient. The hand-powered device may be a squeeze bulb thatprovides suction by means of the energy stored in the material of itsconstruction. Alternatively, the suction device may be powered bysprings that are compressed by the user. The springs can be selected toproduce the clinically desired level of negative pressure. The amount ofsuction provided by these suction devices is therefore dependent on thelevel of force generated by squeezed material or the springs. Unlike amotor driven suction pump, the hand powered device preferably cannotproduce a high level of suction that may cause an adverse effect towound healing.

Referring to FIG. 21, a suction device 61 in the form of a bulbconstructed of a deformable material that stores the energy ofdeformation may be used. The tube 32 communicates with the interior ofthe suction device 61. A one-way exhaust valve 62 also communicates withthe interior of the suction device 61. When the user squeezes thesuction device 61, air within the device is expelled through the exhaustvalve 62. A portion of the energy used to deform the suction device 61is stored in the material of which it is constructed, thus maintainingsuction within the device, as well as within the tube 32 and the chamberspace 24. The bulb is selected and engineered to maintain a constantforce and to maintain the clinically desired level of negative pressurewithin chamber space 24. Fluid from the wound 30 can flow through thetube 32 into the suction device 61 where it can be stored prior todisposal. Once the suction device is full of fluid, the production ofnegative pressure ceases. The fluid capacity of the suction device thusoperates as a safety shut-off mechanism without the need for electronicsensors and controls.

FIG. 22 shows an alternative suction device 63, consisting of flexiblesides 64 and rigid sides 65. Compression springs 66 are located withinsuction device 63. The tube 32 and the exhaust valve 62 both communicatewith the interior of the suction device 63. When the user squeezes therigid sides 65 towards one another, the springs 66 are compressed andair within the device is expelled through a one-way exhaust valve 62thus maintaining suction within the device, as well as within the tube32 and the chamber space 24. The springs 66 are selected and engineeredto maintain a constant force against rigid sides 65, and to maintain theclinically desired level of negative pressure within chamber space 24.Fluid from the wound 30 can flow through the tube 32 into the suctiondevice 63 where it can be stored prior to disposal of the entire device63. This suction device will also cease operating when it is filled withfluid.

FIG. 23 shows an alternative suction device 70, consisting of rigidsides 72, joined by hinge 73, and flexible side 71. A torsional spring74 is attached to either the interior or the exterior of rigid sides 72.The tube 32 and the exhaust valve 62 both communicate with the interiorof the suction device 70. When the user squeezes the rigid sides 72towards one another, the spring 74 is compressed and air within thedevice is expelled through a one-way exhaust valve 62, thus maintainingnegative pressure within the device, as well as within the tube 32 andthe chamber space 24. The spring 74 is selected and made to maintain aforce against rigid sides 72 to maintain the clinically desired level ofnegative pressure within chamber space 24. Fluid from the wound 30 canflow through the tube 32 into the suction device 70 where it can bestored prior to disposal of the entire device. FIG. 24 shows the deviceof FIG. 27 where the torsional spring 74 has been replaced by a flatspring 78.

For the previous suction devices, once suction has been established,fluid may flow from the wound to the suction device, where it may becollected and stored for eventual disposal. Alternatively, a separatefluid collector, such as the fluid collector 60 in FIG. 20, can bepositioned between the chamber and the suction device. Once the suctiondevice has expanded to its original shape, suction ceases. The suctiondevice will not continue to operate, and can be disconnected anddisposed of. If treatment is to be continued, a new suction device canbe connected and activated.

FIG. 25 is a sectional view of a trap 80 and a filter 82 interposedbetween the suction device 34 and the exhaust valve 62 for the purposeof preventing the expulsion of liquids or aerosols from the suctiondevice.

The present disclosure can be engineered to operate at various levels ofnegative pressure, in accordance with clinical procedures. Traditionalnegative pressure wound healing devices can apply a negative pressure ofbetween −0.5 and −2 psi, or about −750 mm Hg to about −125 mm Hg. Thedevice of the present disclosure operates efficiently in this range. Thechamber material conforms to the shape of the wound, and the embossedprojections maintain their shape and functionality. However, the chambercan be engineered to operate at higher levels of negative pressure. Thedevice of the present disclosure may also work efficiently at lessernegative pressures of for example from about 425 mm Hg to about −10 mmHg. The application of less negative pressure may reduce pain and othercomplications. In addition, if a hand-powered suction device is used,the operating pressure of the device may be higher than the commonlyaccepted range; that is, the device may operate at a pressure close to 0psi before suction ceases.

In accordance with one or more embodiments, a negative pressure woundtherapy device may be vacuum-assisted to stimulate blood flow and newblood vessel growth, biomechanically stimulate cells to encouragedivision and proliferation, and to remove factors that might inhibithealing such as bacteria. Depending on the stage of treatment,connecting tubes can plug into different devices to apply negativepressure, drain a wound, and deliver therapeutic agents.

The present disclosure eliminates many of the drawbacks to existingnegative pressure wound therapy systems. For example, the device of thepresent disclosure is preferably simplified and lightweight, and allowsvisual inspection of the wound. In some embodiments of the disclosure,the patient is not restricted to a source of electricity or a batterypack. The system can be worn with ease, so that the patient's mobilityis not otherwise compromised. In addition, the wound interface appliancecan be applied quickly without the need for custom fitting andconstruction. The device preferably does not leak due to the smoothadhesive base, eliminating the need for constant suction from anelectric pump with sophisticated controls and safety measure. There isno interface material such as a porous wound insert that can potentiallycause tissue in-growth and harbor infectious material. Instead, theinner surfaces of the chamber are generally non-porous and non-adherentto prevent any interaction with the wound tissue. Further still, thesuction pump preferably has built-in safety limitations on force ofsuction, duration of operation, and overfilling of the collector forwound fluid. The engineered surface may stimulate the wound and createan efficient pathway for the distribution of negative pressure. Thewound treatment chamber may be customized for use on any body partincluding limbs, as well as the head, face and/or neck. The devices andmethods disclosed herein may be used in conjunction with conventionalwound debridement and grafting techniques without any contraindications.The devices and methods may facilitate the fixation and protection ofskin grafts and micrografts. The devices and methods may be superior toconventional approaches to administering negative pressure in terms ofat least granulation tissue formation.

The function and advantage of these and other embodiments of thematerials and methods disclosed herein will be more fully understoodfrom the examples below. The following examples are intended toillustrate the benefits of the disclosed materials and methods, but donot exemplify the full scope thereof.

EXAMPLE 1

The effectiveness of the raised structures in distributing andmaintaining negative pressure within the chamber and across the woundsurface was demonstrated in a test model. A wound was created in asample of animal cadaver tissue. A pressure sensor was installed in thetissue at the center of the wound. A wound chamber device with raisedengineered structures on the interior chamber wall was sealed to theskin around the wound. A tube from the chamber device was connected to asource of suction capable of delivering a range of negative pressure.The amount of negative pressure measured at the suction source wascompared to the measurement at the center of the wound, in order todetermine the effectiveness of the device with respect to thedistribution of negative pressure to the wound. The following valueswere obtained:

Pressure at Source (mmHg) Pressure in Wound (mmHg) −80 −65 (81.25%efficiency) −100 −86 (86.00% efficiency) −120 −100 (83.33% efficiency) 

The raised structures were observed to maintain their shape with nodeformation, thereby preserving their functionality.

EXAMPLE 2

A patient with a full thickness skin wound was treated with a woundchamber negative pressure device connected to a hand-powered suctionpump. The interior surface of the chamber contained embossed raisedstructures. The area around the wound was treated with normal skindisinfectants. The backing from the adhesive base of the chamber wasremoved, and the chamber was sealed to the normal skin around the wound.The tube was connected to a modified squeeze bulb with an inlet port forfluid, and an exhaust port through which air can be expelled from thebulb. By squeezing the bulb down to its flattest configuration, anegative pressure of 2 pounds per square inch was established andmaintained within the chamber. After the first twenty-four hours oftreatment, the squeeze bulb had expanded to approximately half of itsnormal size. The bulb was compressed again to its fully flattenedconfiguration. The bulb remained in such configuration for an additionaltwelve hours, at which point the chamber was removed. The wound showedhealthy granulation tissue and progressed to heal rapidly and withminimal scarring. The device produced no adverse effects on the wound orthe surrounding skin.

PROPHETIC EXAMPLE

Aspects of the present disclosure may be illustrated by the followingprophetic example addressing injuries commonly resulting from militarycombat.

A patient was presented with partial and full thickness burns to thehead, face, and neck. After evaluation, the wounds were thoroughlycleaned and dead tissue was removed. The patient's mouth and nose wereclosed with sutures. The patient was fitted with a tracheostomy tube anda gastrostomy tube. Protective lenses were inserted into the patient'seyes. A negative pressure device described herein having an oversizedtransparent chamber with internally embossed surface structures wasapplied over the patient's head and neck and sealed proximate the collarbone, above the tracheostomy and gastrostomy tubes.

The wound was treated according to the following regimen: in the first24 hours, pain medication and chemical debriding agents were applied tothe wounds by introducing the agents into the wound chamber, followed byhigh concentrations of anti-inflammatories, antibiotics, andantimicrobials to inhibit biofilm formation. The wounds were thenchemically debrided a second time.

Negative pressure therapy was then applied for a time sufficient toprepare the wounds for skin grafts, for example, about 48 to 72 hours.During negative pressure therapy, the wounds were monitored by visualinspection through the transparent material of the chamber and bysampling the wound fluid for detection of bacteria. The negativepressure device was then removed and the wounds were treated with skinmicrografts. The wounds were again covered by a new negative pressurechamber and therapeutic agents and negative pressure therapy wereapplied. The chamber helped maintain the skin grafts in place and thenegative pressure therapy device stimulated cell and blood vessel growthto facilitate integration of the skin graft. Therapeutic agents werealso applied as necessary to achieve optimal healing. The negativepressure chamber was replaced periodically, for example weekly orbiweekly. The result was healed wounds with minimal scarring. Dedicatedscar treatment followed to complete recovery.

It is to be appreciated that embodiments of the methods, devices, andapparatuses discussed herein are not limited in application to thedetails of construction and the arrangement of components set forth inthe above description or illustrated in the accompanying drawings. Themethods, devices, and apparatuses are capable of implementation in otherembodiments and of being practiced or of being carried out in variousways. Examples of specific implementations are provided herein forillustrative purposes only and are not intended to be limiting. Inparticular, acts, elements and features discussed in connection with anyone or more embodiments are not intended to be excluded from a similarrole in any other embodiment.

Also, the phraseology and terminology used herein is for the purpose ofdescription and should not be regarded as limiting. Any references toembodiments or elements or acts of the systems and methods hereinreferred to in the singular may also embrace embodiments including aplurality of these elements, and any references in plural to anyembodiment or element or act herein may also embrace embodimentsincluding only a single element. The use herein of “including,”“comprising,” “having,” “containing,” “involving,” and variationsthereof is meant to encompass the items listed thereafter andequivalents thereof as well as additional items. References to “or” maybe construed as inclusive so that any terms described using “or” mayindicate any of a single, more than one, and all of the described terms.Any references to front and back, left and right, top and bottom, upperand lower, and vertical and horizontal are intended for convenience ofdescription, not to limit the present devices and methods or theircomponents to any one positional or spatial orientation.

Having described above several aspects of at least one embodiment, it isto be appreciated that various alterations, modifications, andimprovements will readily occur to those skilled in the art. Suchalterations, modifications, and improvements are intended to be part ofthis disclosure and are intended to be within the scope of theinvention. Accordingly, the foregoing description and drawings are byway of example only.

What is claimed is:
 1. A device for wound treatment, comprising: achamber that includes an inner surface and a sealing portion thatdefines an isolated treatment space; a plurality of embossed structuresarranged in a pattern on the inner surface of the chamber, thestructures having a height of about 0.2 mm to about 5 mm and spacedabout 0.2 mm to about 10 mm from one another, the structures configuredto directly contact a wound and to create pathways for distributingnegative pressure between the inner surface of the chamber and thewound; and at least one tube having a first end connected to thechamber, the at least one tube being in fluid communication with theisolated treatment space so as to enable at least one selected from thegroup of applying negative pressure to the isolated treatment space andapplying a therapeutic agent to the wound.
 2. The device of claim 1,wherein the chamber is configured to form an isolated treatment spaceover a head and neck of a human patient.
 3. The device of claim 2,wherein the chamber is formed from a single sheet of material.
 4. Thedevice of claim 2, wherein the chamber is formed from two or more sheetsof material that are configured to seal together to define the isolatedtreatment space.
 5. The device of claim 4, wherein the seal is one of amechanical seal or an adhesive seal.
 6. The device of claim 1, whereinthe plurality of structures intrudes into the isolated treatment spacein a direction generally perpendicular to the inner surface of thechamber.
 7. The device of claim 1, wherein each embossed structure has ashape selected from the group consisting of a cone, a pyramid, apentagon, a hexagon, a half sphere, a dome, a rod, an elongated ridgewith rounded sides, and an elongated ridge with square sides.
 8. Thedevice of claim 1, wherein the chamber is made of a substantiallytransparent material.
 9. The device of claim 1, wherein the therapeuticagent may be applied to the wound at a concentration that is up to orgreater than about 1000 times a recommended intravenous treatmentconcentration.
 10. The device of claim 1, wherein the at least one tubeis further configured to remove wound fluid from the treatment space.11. A wound treatment device, comprising: a chamber configured toenclose a head and neck region of a patient, the chamber being made ofan impermeable material that is sufficiently thin to conform to the headand neck of the patient, the chamber having a sealing portion at a baseand an interior surface defining an isolated treatment space; aplurality of embossed structures on the interior surface of the chamber,the structures being configured to directly contact a wound and tocreate pathways for distributing negative pressure between the innersurface of the chamber and the wound; and at least one tube connected tothe chamber and in fluid communication with the isolated treatment spaceso as to enable at least one selected from the group of applyingnegative pressure to the treatment space and applying a therapeuticagent to the wound.
 12. The device of claim 11, wherein the chamber wallis substantially transparent.
 13. The device of claim 11, wherein thetherapeutic agent may be applied at a concentration that is up to orgreater than about 1000 times a recommended intravenous treatmentconcentration.
 14. The device of claim 11, wherein the plurality ofembossed structures have a height of about 0.1 mm to about 5 mm.
 15. Thedevice of claim 14, wherein the plurality of embossed structures arepositioned at a distance of about 0.2 mm to about 10 mm apart from oneanother.
 16. The device of claim 17, wherein the plurality of theembossed structures are positioned in a uniform pattern on the innersurface.
 17. The device of claim 16, wherein each embossed structure hasa shape selected from the group consisting of a cone, a pyramid, apentagon, a hexagon, a half sphere, a dome, a rod,


18. The device of claim 11, wherein the device is configured to treatthe wound for a prolonged duration of a healing process.
 19. A method oftreating a patient having a facial wound, comprising: debriding thefacial wound; fitting a wound treatment device of claim 11 over a headof the patient; applying at least one therapeutic agent to the wound viathe device at a concentration of up to or greater than about 1000 timesa concentration suitable for intravenous delivery; and applying negativepressure wound therapy to the treatment space of the device for asufficient duration to effect healing of the wound.
 20. The method ofclaim 19, further comprising surgically or non-surgically closing amouth and a nose of the patient; applying a protective shield over aneye of the patient; and applying a tracheostomy tube and a gastrostomytube to the patient.